Testing low-cost prosthetic (or artificial) arm developed for childre

Not Applicable

Conditions: Health Condition 1: Z892- Acquired absence of upper limb above wristHealth Condition 2: Q719- Unspecified reduction defect of upper limb

Registration Number: CTRI/2020/06/025670

Lead Sponsor: The University of Oxford

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Boy or girl, aged three years to 17 years including non-wearers of a prosthetic device.

2. Individuals with a bilateral level of amputation and non-disabled children (only Stage I).

3. The participantâ??s parent or the legal guardian is willing and able to give permission and informed assent for his or her wardâ??s participation in the study.

4. Be free of neurological and musculoskeletal pathology (apart from upper limb (UL) amputation or loss for prosthesis users, and as reported by the participants or their clinician) that would impair UL motor control during goal-oriented task execution in a seated position.

Exclusion Criteria

The participant may not enter the study if ANY of the following apply:

1. Generally, any medical conditions, assessed by their treating healthcare professionals, that would contraindicate the use of our prosthetic arm prototypes, such as difficulties in breathing, skin abrasions, and musculoskeletal injuries.

2. Inability to give the information required or to perform the test tasks.

3. Wounds or ulcers in the residuum.

4. Individuals with a transcarpal level of amputation (for Stage II).

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stage I: <br/ ><br>â?? Qualitative feedback provided by the study participants and their parent(s) or legal guardian via a questionnaire; Researcher-observed data <br/ ><br> <br/ ><br>Stage II: <br/ ><br>â?? Published outcome measures such as babySHAP, PUFI, and PODCI (or PedsQL) tests.Timepoint: 36 months from the date of study approval

Secondary Outcome Measures

Name	Time	Method
Stage I: <br/ ><br>â?? A questionnaire-based survey by the study participants and their parent(s) or legal guardian via questionnaires (QUEST 2.0 and Nagaraja et al. 2016). <br/ ><br> <br/ ><br> <br/ ><br>â?? Published outcome measures such as babySHAP and UNB tests.Timepoint: 36 months from the date of study approval